First results of the rwe prospective study TEC care (IFM 2023-01) evaluating teclistamab in triple-class exposed relapsed refractory multiple myeloma patients.

Abstract Introduction Teclistamab was the first approved BCMAxCD3 bispecific antibody for the treatment of patients with relapsed refractory multiple myeloma (RRMM) previously exposed to a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody based on the data from MajesTEC-1 clinical trial. To date, several retrospective studies reporting teclistamab outcomes in the real world have been published, but inherent limitations of these cohorts make prospective RWE studies necessary. Here, we present the results from the first interim analysis of Tec-Care, the first prospective study describing real-world effectiveness and safety of teclistamab in triple-class exposed RRMM. Methods Tec-Care is a prospective, multicenter, observational study from the Intergroupe Francophone du Myelome (IFM 2023-01). Patients could be included in the study if they had confirmed RRMM and had received at least one dose of teclistamab through the French early access program. The primary objective of the study was the overall response rate (ORR). Secondary objectives included very good partial response rates (VGPR), complete response rates (CR), time to next treatment (TTNT), progression-free survival (PFS), overall survival (OS), safety and treatment management. Results A total of 199 patients were enrolled in 31 IFM centers from September 2023 to December 2024. Median age was 73.2 years old [range 45-94]and median number of prior lines was 4 [range 1-15]. 65.8% of patients were triple-class refractory and 30.2% were penta-refractory. 27 patients (13.6%) received prior anti BCMA therapy. 19% of patients had extramedullary disease and 32% had high risk cytogenetics. With a median follow-up of 10.6 months, the 6-months ORR was 65.8% with 53.3% being VGPR or better. Response rates were consistent between the overall cohort and the subgroups analyzed. At 10 months, estimate PFS and OS rates were 56% [CI 95% 49%-63%] and 68,5% [CI 95% 61%-75%], but longer follow up is needed. Regarding safety, cytokine release syndrome (CRS) occurred in 66 (33.2%) patients (no grade >2), Immune cell-associated neurotoxicity syndrome (ICANS) occurred in 8 (4%) patients (including 1 grade 3), 36.8% of patients experienced grade >=2 infection with 12.6% of grade 3 or more, 71.4 % of patients received at least one polyvalent immunoglobulin dose since teclistamab initiation with a median starting time of 19 days (IQR 9-39), 12% of patients received at least one outpatient administration of teclistamab step-up doses. ConclusionIn conclusion, the prospective TEC CARE study confirms the effectiveness and safety profile of teclistamab in real-world patients with triple-class exposed relapsed/refractory multiple myeloma (RRMM), consistent with clinical trial data, thereby supporting its use as a standard treatment in this setting.

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Journal
Blood
Published
2025-11-03
DOI
https://doi.org/10.1182/blood-2025-5836
Primary Topic
Multiple Myeloma Research and Treatments
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article
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article

First results of the rwe prospective study TEC care (IFM 2023-01) evaluating teclistamab in triple-class exposed relapsed refractory multiple myeloma patients.

Ariane Boumendil, Karim Belhadj Merzoug, Marie Pierrès, Driss Chaoui et al.
Blood
Multiple Myeloma Research and Treatments
article

First results of the rwe prospective study TEC care (IFM 2023-01) evaluating teclistamab in triple-class exposed relapsed refractory multiple myeloma patients.

Ariane Boumendil, Karim Belhadj Merzoug, Marie Pierrès, Driss Chaoui, Stéphanie Harel, Véronique Dorvaux, Hélène Demarquette, Claire Bréal, Salomon Manier, M. Macro, Pascal Lenain, Virginie Roland, Julie Gay, Jean‐Marc Schiano de Colella, Cyrille Touzeau, Riad Benramdane, Edmond Chiche, Laure Vincent, Thomas Chalopin, Aurore Perrot, Lydia Montes, Émilie Chalayer, Laurent Frenzel, Andrea Pieragostini, Carolyne Croizier, Philippe Moreau, Stéphane Moreau, Olivier Decaux, D Arthur, Cyrille Hulin, Frédérique Orsini Piocelle, S. Gil Vernet, Marie Odile Petillon, Jean Eudes Fontan, Cecile Sonntag Mottier, Cherel Brieuc, Veronique Vitry
article en

Abstract

Abstract Introduction Teclistamab was the first approved BCMAxCD3 bispecific antibody for the treatment of patients with relapsed refractory multiple myeloma (RRMM) previously exposed to a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody based on the data from MajesTEC-1 clinical trial. To date, several retrospective studies reporting teclistamab outcomes in the real world have been published, but inherent limitations of these cohorts make prospective RWE studies necessary. Here, we present the results from the first interim analysis of Tec-Care, the first prospective study describing real-world effectiveness and safety of teclistamab in triple-class exposed RRMM. Methods Tec-Care is a prospective, multicenter, observational study from the Intergroupe Francophone du Myelome (IFM 2023-01). Patients could be included in the study if they had confirmed RRMM and had received at least one dose of teclistamab through the French early access program. The primary objective of the study was the overall response rate (ORR). Secondary objectives included very good partial response rates (VGPR), complete response rates (CR), time to next treatment (TTNT), progression-free survival (PFS), overall survival (OS), safety and treatment management. Results A total of 199 patients were enrolled in 31 IFM centers from September 2023 to December 2024. Median age was 73.2 years old [range 45-94]and median number of prior lines was 4 [range 1-15]. 65.8% of patients were triple-class refractory and 30.2% were penta-refractory. 27 patients (13.6%) received prior anti BCMA therapy. 19% of patients had extramedullary disease and 32% had high risk cytogenetics. With a median follow-up of 10.6 months, the 6-months ORR was 65.8% with 53.3% being VGPR or better. Response rates were consistent between the overall cohort and the subgroups analyzed. At 10 months, estimate PFS and OS rates were 56% [CI 95% 49%-63%] and 68,5% [CI 95% 61%-75%], but longer follow up is needed. Regarding safety, cytokine release syndrome (CRS) occurred in 66 (33.2%) patients (no grade >2), Immune cell-associated neurotoxicity syndrome (ICANS) occurred in 8 (4%) patients (including 1 grade 3), 36.8% of patients experienced grade >=2 infection with 12.6% of grade 3 or more, 71.4 % of patients received at least one polyvalent immunoglobulin dose since teclistamab initiation with a median starting time of 19 days (IQR 9-39), 12% of patients received at least one outpatient administration of teclistamab step-up doses. ConclusionIn conclusion, the prospective TEC CARE study confirms the effectiveness and safety profile of teclistamab in real-world patients with triple-class exposed relapsed/refractory multiple myeloma (RRMM), consistent with clinical trial data, thereby supporting its use as a standard treatment in this setting.

BloodVol. 146(Supplement 1)
Université de Tours (FR), Georgia Tech Lorraine (FR), Hôpital Necker-Enfants Malades (FR), Sciences Po Bordeaux (FR), Université de Bordeaux (FR), Université de Perpignan (FR), Université de Lille (FR), Centre Hospitalier Universitaire de Lille (FR), Centre Hospitalier Universitaire Henri-Mondor (FR), Université Rennes 2 (FR), Centre Hospitalier Universitaire de Besançon (FR), Centre Hospitalier de Perpignan (FR), Institut de Cancérologie Strasbourg (FR), Johnson & Johnson (France) (FR), Centre Hospitalier Universitaire de Tours (FR), Centre Hospitalier Universitaire Amiens-Picardie (FR), Assistance Publique – Hôpitaux de Paris (FR), Institut universitaire du cancer de Toulouse Oncopole (FR), Centre Hospitalier de Bretagne Sud (FR), Laboratoire d'Informatique, de Robotique et de Microélectronique de Montpellier (FR), Centre Hospitalier Métropole Savoie (FR), Laboratoire de Physique Corpusculaire de Caen (FR), Centre hospitalier Bretagne Atlantique (FR), Centre Hospitalier Universitaire de Caen Normandie (FR), Laboratoire d'Étude des Microstructures et de Mécanique des Matériaux (FR), 3M (France) (FR), Intergroupe Francophone du Myélome (FR), Centre Hospitalier de la Côte Basque (FR), Centre d'Investigation Clinique de Nantes (FR), Centre Hospitalier Universitaire de Clermont-Ferrand (FR), Hôpitaux Universitaires Henri-Mondor (FR), Centre Hospitalier Annecy Genevois (FR), Centre Hospitalier Victor Dupouy (FR), Laboratoire d'Informatique Fondamentale et Appliquée de Tours (FR), Observatoire des Sciences de l’Univers Terre Homme Environnement Temps Astronomie (FR), Laboratoire National Henri Becquerel (FR), Maison des Sciences sociales et des Humanités de Dijon (FR), Hôpital Saint-Louis (FR), Equipes Traitement de l'Information et Systèmes (FR), Institut Paoli-Calmettes (FR), Centre Hospitalier Universitaire de Saint-Étienne (FR), Société Francophone du Diabète (FR), Institut Polytechnique de Bordeaux (FR), Université de Rennes (FR), University of Castilla-La Mancha (ES), Université de Caen Normandie (FR)
Openalex Percentile: Top 49%
Multiple Myeloma Research and Treatments
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